Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Label indication LOQTORZI is a programmed death receptor-1 (PD-1)- blocking antibody indicated: in combination with cisplatin and gemcitabine, for first-line treatment of adults with metastatic or with recurrent locally advanced nasopharyngeal carcinoma (NPC) ( 1.1 ) as a single agent for the treatment of adults with recurrent unresectable or metastatic NPC with disease progression on or after a platinum-containing chemotherapy (… FDA label
Also known as Toripalimab-tpzi, Loqtorzi, Anti-PD-1 Monoclonal Antibody JS001, JS-001, TAB-001, CHS-007
Toripalimab · 7 trials · 19 indications
Determine cCR score by achieving all of these:1 * No lesion, budding, or ulceration identified on esophagogastroduodenoscopy (EGD). * Bite-on-bite biopsies with no residual tumor. * EGD with endoscopic ultrasound (EUS) and fine needle aspiration (FNA) of suspicious lymph nodes (LNs) shows no residual tumor. If patients have suspicious LNs unable to be reached by FNA, they will not be classified as clinical complete responders.
Proportion of patients who have not experienced disease recurrence/progression or death from any cause at 1 year from start of treatment. Radiologic (CT or MRI) imaging as well as direct visualization by laryngoscopy will be used to assess disease with recurrence requiring a biopsy to be considered positive.
Time between the date of registration and the first date of documented recurrence, regardless of discontinuation of study drug, or death due to any cause, assessed at 3 years
pTRR is defined as the proportion of participants that experience a complete pathologic response or partial pathologic response during treatment, as defined in the RECIST criteria.
Phase 2: Safety of treatment, defined as the frequency and percentage of DLTs, from start of treatment up to 30 days post the last administration of study drug (dupilumab).
For the Phase 1b portion, Dose-Limiting Toxicities (DLTs) will be assessed based on the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Adverse events are graded on a scale from 1 (mild) to 5 (death related to AE). Permanent discontinuation of study treatment will occur for any severe (Grade 3) drug-related adverse event that recurs or for any life-threatening (Grade 4) event.
For the phase 2 portion, ORR will be assessed based on the definition, as the combined percent of the subjects experiencing a partial response (PR) or a complete response (CR) at anytime within the first year from the initiation of therapy, or until the documented progression of disease or start of a new anti-cancer therapy. Radiographic response will be determined by the RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| Toripalimab + CRT | EXPERIMENTAL | Intravenous (IV) toripalimab infusions on Day 1 of each 21-day treatment cycle for 2 doses prior to dCRT followed by adjuvant toripalimab for up to 1 year. No toripalimab will be given during SOC dCRT. After dCRT, all patients can progress to adjuvant toripalimab or resection followed by adjuvant toripalimab. After adjuvant toripalimab, routine surveillance will involve serial esophagogastroduodenoscopies (EGDs) and imaging. Treatment will continue for up to an additional year with adjuvant toripalimab infusions, until disease progression, or intolerable toxicity. Patients will be followed for OS and subsequent anticancer therapy for up to 3 years after ending study treatment. Note: Toripalimab will be provided to the study by Coherus. Each site will obtain carboplatin and paclitaxel from commercial supply to administer as standard of care. |
| NY-ESO-1 Peptide vaccine plus Toripalimab-tpzi | EXPERIMENTAL | - |
| toripalimab + carboplatin + paclitaxel | EXPERIMENTAL | Prior to treatment: Assessments include laryngoscopy and anatomic imaging studies Treatment: toripalimab 240mg IV with carboplatin (AUC 5) and paclitaxel (175 mg/m\^2) IV every 3 weeks for two cycles. (Cisplatin 75mg/m\^2 can be used in place of carboplatin at the investigator's discretion.) After 2 Cycles of Treatment: Repeat laryngoscopy and anatomic imaging studies. Undergo swallowing function and extranodal extension status assessment. |
| Post-bioselection: Chemoradiation + toripalimab monotherapy | EXPERIMENTAL | Patients with PR ≥50% (not CR) with preserved swallowing function or CR, with preoperative N+ disease and extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: toripalimab 240mg IV + carboplatin (AUC 5) + paclitaxel (175 mg/m\^2) IV Q + Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles |
| Post-bioselection: Radiation + toripalimab monotherapy | EXPERIMENTAL | Patients with CR, with preoperative N0 disease or N+ disease with no extranodal extension upon neck dissection. Induction Treatment: toripalimab 240mg IV+carboplatin (AUC 5)+paclitaxel (175 mg/m\^2) IV Q Continuation Treatment: Radiation therapy as per the Intervention Description + toripalimab 240mg IV monotherapy for 8 cycles |
| Treatment (toripalimab) | EXPERIMENTAL | Eligible consenting participants receive toripalimab intravenously every 3 weeks for 6 months (8 doses) in the absence of disease recurrence or unacceptable toxicity. Following this, patients undergo surveillance follow up with blood tests, computed tomography (CT) scans, colonoscopy at specified intervals until 5 years post-resection. For patients who have a recurrence, a biopsy will be performed at the time of recurrence. |
| Arm 1: Toripalimab and Docetaxel Plus Carboplatin (TCD) | EXPERIMENTAL | * Baseline visit with imaging * Cycles 1 and 2 (21 day cycles) * Day 1: Predetermined dose of Toripalimab 1x daily * Day 1: Chemotherapy: predetermined dose of Docetaxel 1x daily and Carboplatin 1x daily * Tumor assessment by imaging * Surgical resection of tumor |
| Arm 2: Post Operative Radiation Therapy + Toripalimab | EXPERIMENTAL | After pathology assessment, participants with a pathological treatment response of 2 will be assigned radiation therapy per standard practice guidelines and predetermined dose of Toripalimab 1x every 3 weeks for up to 8 cycles (21 day cycles). -Follow up: every 3 months for 1 year. Imaging at 3 months |
| Arm 3: Post Operative Radiation Therapy With or Without Chemotherapy | EXPERIMENTAL | After pathology assessment, participants with a pathological treatment response of 2 or less will be assigned standard radiation therapy with or without standard of care Cisplatin-based chemotherapy as recommended per treatment team and standard practice guidelines. -Follow up: every 3 months for 1 year. Imaging at 3 months |
| Dupilumab and toripalimab | EXPERIMENTAL | Participants will receive the combination of Dupilumab and Toripalimab |
| Nadunolimab and Toripalimab | EXPERIMENTAL | Participants will receive the investigational combination of nadunolimab and toripalimab. Treatment will continue for up to 1 year or until disease progression, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Toripalimab | DRUG | Injection Q3W at 240mg doses |
| Carboplatin + Paclitaxel | DRUG | Carboplatin AUC 2 Q1W Infusion, Paclitaxel Q1W Infusion 50mg/m2 |
| NY-ESO-1 Peptide vaccine | BIOLOGICAL | 300 mcg of NY-ESO-1 peptide, 100 micrograms (mcg) granulocyte-macrophage colony-stimulating factor (GM-CSF) and 1 milliliter (mL) of Montanide ISA-51 adjuvant. The first two doses will be administered subcutaneously in a 2 week interval and thereafter, remaining three doses will be administered every 3 weeks. |
| Toripalimab-tpzi | DRUG | 240 milligrams (mg), intravenously, every 3 weeks starting with the second dose of NY-ESO-1 Peptide vaccine |
| Carboplatin | DRUG | A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells. |
| Cisplatin | DRUG | \*Can be used in place of carboplatin at the investigator's discretion. A chemotherapy medication classified as an alkylating agent. It contains the metal platinum, which binds to DNA in cancer cells, preventing their replication and leading to cell death. This mechanism makes it effective against rapidly dividing cells, such as cancer cells. |
| Paclitaxel | DRUG | A chemotherapy drug that works by slowing or stopping cancer cell growth. |
| Radiation Therapy | RADIATION | Megavoltage energy photon beam irradiation. Any treatment planning and delivery system that has been credentialed for head and neck intensity-modulated radiotherapy (IMRT). Simultaneous integrated boost and sequential boost techniques (discretion of treating physician). Total doses delivered to each Planning Target Volume (PTV) (in 33-35 fractions): High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60-63 Gy, Elective: 56-57 Gy A sequential boost will consist of treatment of the combined PTVs 25 fractions followed by three sequential cone-downs targeting (Intermediate + Boost + High); (Boost + High); and High. Total doses for the PTVs: High: 70 Gy, Boost (if applicable): 66 Gy, Intermediate: 60 Gy, Elective: 50 Gy. |
| Biopsy Procedure | PROCEDURE | Undergo biopsy |
| Biospecimen Collection | PROCEDURE | Undergo collection of blood samples |
| Colonoscopy | PROCEDURE | Undergo colonoscopy |
| Computed Tomography | PROCEDURE | Undergo CT |
| Questionnaire Administration | OTHER | Ancillary studies |
| Docetaxel | DRUG | A taxoid antineoplastic agent, single-dose vials, via intravenous (into the vein) infusion per standard of care. |
| Dupilumab | DRUG | Dupilumab is commercially sourced, and provided as 300mg pre-filled syringes, though packaging may vary. Dupilumab 600mg SC on Day 1 and 300mg SC on Day 15 (+/-2 days). |
| Nadunolimab | DRUG | 5 mg/kg intravenously (IV) every 3 weeks (Q3W) |
Inclusion Criteria: 1. Signed and dated written informed consent. 2. Age ≥ 18 years the day of signing informed consent. 3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1. 4. Previously untreated, resectable, histologically confirmed stage II-IVA esophageal squamous cell carc...
Toripalimab is being studied in several cancers, including esophageal squamous cell carcinoma, head and neck squamous cell carcinoma, localized colon carcinoma, metastatic colorectal cancer, metastatic microsatellite stable colorectal carcinoma, and stage IV ovarian cancer. It is an investigational therapy and is not described as approved for these uses.
Toripalimab targets PDCD1, also known as PD-1. It is a monoclonal antibody that acts as an antagonist at this receptor. By binding PDCD1, the drug is designed to interfere with PD-1 mediated signaling in the tumor microenvironment, a mechanism intended to support antitumor immune activity.
Toripalimab is being developed by Coherus Oncology, Inc., which trades under the ticker CHRS. The company is the sponsor associated with the clinical development program covering the esophageal, head and neck, and colorectal cancer studies listed for this asset.
Toripalimab is in Phase 2 development. The program includes Phase 2 studies in esophageal squamous cell carcinoma and head and neck squamous cell carcinoma, along with Phase 1 studies in colorectal cancer settings. It is investigational and remains in clinical development.
Toripalimab is being evaluated in NCT07836049, a Phase 2 study in locally advanced esophageal squamous cell carcinoma, and NCT07423078, a Phase 2 laryngeal function preservation trial in head and neck squamous cell carcinoma. Phase 1 studies include NCT07281716 in metastatic microsatellite stable colorectal carcinoma and NCT07277322 in resectable liver metastases.
Yes, toripalimab-tpzi is an alternative name for toripalimab. The suffix identifies the specific monoclonal antibody product. Both names refer to the same PDCD1-targeted agent being developed by Coherus Oncology, Inc. under the ticker CHRS.